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Regulatory Update, January 2015

Thursday, January 1, 2015

FDA draft guidance for laboratory developed tests

The FDA has announced availability of a draft guidance titled Framework for Regula­tory Oversight of Laboratory Developed Tests (LDTs). This document describes a risk-based framework for addressing the regulatory over­sight of a subset of in vitro diagnostic (IVD) devices called LDTs, intended for clinical use and designed, manufactured and used within a single laboratory. This document describes the FDA’s priorities for enforcing pre- and post-market requirements for LDTs, and the process by which the FDA intends to phase in enforcement of FDA regulatory requirements for LDTs over time.

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